Essential TremorrTMSNCT06145932
Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor
A study testing real rTMS in people with Essential Tremor, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and electrophysiology of repetitive transcranial magnetic stimulation in the treatment of essential tremor. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- real rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as essential tremor conforming to the diagnostic criteria for essential tremor in the tremor group of the International Parkinson's and Movement Disorders Society (IPMDS).
- Signed informed consent form.
Who cannot join
- Complicated with brain organic diseases, epilepsy, other mental diseases, family history of dementia, metal devices implanted in the body and any contraindications to TMS;
- History of craniocerebral surgery;
- TMS cannot cooperate;
- TMS-EEG examination artifacts are obvious, or cannot be analyzed due to other technical reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou
yu xiao chen, PHD
About this study
Official title: the Effects of Repetitive Transcranial Magnetic Stimulation and Mechanisms in Clinical Function of Essential Tremor
The purpose of this study is to evaluate the efficacy and electrophysiology of repetitive transcranial magnetic stimulation in the treatment of essential tremor.
Read the detailed description
This is a randomized controlled study.The purpose is to evaluate the efficacy of repetitive transcranial magnetic stimulation(rTMS) in the treatment of essential tremor,and explore the possible mechanism by detecting the changes of clinical scale and TMS-electroencephalogram(TMS-EEG), so as to seek an effective therapy for essential tremor.
- Conditions
- Essential Tremor
- Being tested
- real rTMS, sham rTMS
- Keywords
- Essential Tremor, Transcranial magnetic stimulation
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real rTMSDevice
treated with 1HZ rTMS 1800 pulses / day,for 10 days
sham rTMSDevice
treated with sham rTMS 1800 pulses / day,for 10 days
| Study group | Role | What they receive |
|---|---|---|
| rTMS treatment group | Experimental | treated with real rTMS 1800 pulses / day,for 10 days Receives: Device: real rTMS |
| Sham rTMS treatment group | Sham comparator | treated with sham rTMS 1800 pulses / day,for 10 days Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score
The TETRAS is widely used tremor evaluation scale.TETRAS has been used for evaluation tremor in patients with essential tremor focuses primarily on the assessment of activities of daily living and tremor.The TETRAS score ranges from 0 to 112. The higher the TETRAS score, the more severe the symptoms.
Measured: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Changes from baseline in tremor analysis
This outcome reflects quantitative changes in the patient's tremor.
Measured: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Secondary outcomes (13)
Changes from baseline in TMS-EEG
Amplitudes of various frequency bands in each cortical region of TMS-EEG reflects change in the patient's brain network.
Measured: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Change in Non-Motor Symptoms Rating Scale (NMSS) score from baseline
This outcome reflects the efficacy of non-motor symptoms. NMSS is a widely used non-motor symptom rating scale that includes 9 domains, The NMSS score ranges from 0 to 360，with higher scores associated with more severe symptoms.
Measured: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Change in Mini-Mental State Examination (MMSE) score from baseline
The MMSE is widely used to assess cognition. The MMSE score ranges from 0 to 30. The higher the MMSE score is, the better the cognitive function is.
Measured: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Change in Montreal Cognitive Assessment (MOCA) score from baseline
MoCA is widely used to assess cognitive abilities. MOCA scores range from 0 to 30. The higher the MOCA score, the better the cognitive function.
Measured: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Changes from baseline in Hamilton Anxiety Scale(HAMA) score
The Hamilton Anxiety Scale(HAMA) is a widely used interview scale to measure the severity of a patient's anxiety.The HAMA score can range from 0 to 56. The higher the HAMA score is, the worse the symptoms are.
Measured: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score
The Hamilton Depression Scale-24(HAMD-24) is a test measuring the severity of depressive symptoms in individuals. The HAMA score can range from 0 to 56. The higher the HAMA score is, the worse the symptoms are.
Measured: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Quality of Life Questionnaire (QUEST) score change from baseline
This outcome reflects the patient's quality of life. QUEST scores range from 0 to 120.
The higher the QUEST score, the more severe the symptoms.
Measured: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline
PSQI is widely used to measure sleep quality. PSQI scores range from 0 to 21. The higher the PSQI score, The worse the quality of sleep.
Measured: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Change in Fatigue Severity Scale (FSS) score from baseline
FSS is widely used in the assessment of fatigue. Indicates a health problem associated with fatigue. The higher the score, the worse the fatigue
Measured: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
RBD Screening Questionnaire (RBDSQ) score
There are 10 questions in total, including the content of dreams, the relationship between dreams and behavior, injuries and neurological diseases, etc. The total score is 0-13 points, and a score of 5 or above is considered abnormal.
Measured: visit 1(baseline)
Test the sleep characteristics by polysomnography (PSG)
This outcome reflects the patient's sleep characteristics and to analyze specific events.
Measured: visit 1(baseline)
test the characteristics of vestibular evoked myogenic potential (VEMP)
This is a commonly used clinical test that includes cervical vestibular evoked myogenic potential (cvemp) and ocular vestibular evoked myogenic potential (oVEPM) to assess a patient's brainstem pathways.
Measured: visit 1(baseline)
test the gene's type of the notch2nlc
This outcome reflects the genetic diagnosis characteristics of the patient and is helpful for accurate clinical diagnosis and classification
Measured: visit 1(baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start7 Nov 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-Feng Liu, Second Affiliated Hospital of Soochow University
- Investigators
- Chun-Feng Liu, Principal investigator, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145932
- Sponsor's protocol ID
- JD-LK2023096-IR01
- Acronym
- rTMS
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gironell A, Kulisevsky J, Lorenzo J, Barbanoj M, Pascual-Sedano B, Otermin P. Transcranial magnetic stimulation of the cerebellum in essential tremor: a controlled study. Arch Neurol. 2002 Mar;59(3):413-7. doi: 10.1001/archneur.59.3.413.
PubMed 11890845Lv Y, Wang M, Yang J, Shi J, Xuan T, Zhang J, Du D, Cheng J, Li H. Cerebellar repetitive transcranial magnetic stimulation versus propranolol for essential tremor. Brain Behav. 2023 Mar;13(3):e2926. doi: 10.1002/brb3.2926. Epub 2023 Feb 17.
PubMed 36806734Louis ED, Ferreira JJ. How common is the most common adult movement disorder? Update on the worldwide prevalence of essential tremor. Mov Disord. 2010 Apr 15;25(5):534-41. doi: 10.1002/mds.22838.
PubMed 20175185Louis ED. The Roles of Age and Aging in Essential Tremor: An Epidemiological Perspective. Neuroepidemiology. 2019;52(1-2):111-118. doi: 10.1159/000492831. Epub 2019 Jan 9.
PubMed 30625472Bal N, Sengul Y, Behmen MB, Powell A, Louis ED. Vestibular reflexes in essential tremor: abnormalities of ocular and cervical vestibular-evoked myogenic potentials are associated with the cerebellum and brainstem involvement. J Neural Transm (Vienna). 2023 Dec;130(12):1553-1559. doi: 10.1007/s00702-023-02652-3. Epub 2023 May 18.
PubMed 37199795Berkiten G, Tutar B, Atar S, Kumral TL, Salturk Z, Akan O, Sari H, Onaran O, Biltekin Tuna O, Uyar Y. Assessment of the Clinical Use of Vestibular Evoked Myogenic Potentials and the Video Head Impulse Test in the Diagnosis of Early-Stage Parkinson's Disease. Ann Otol Rhinol Laryngol. 2023 Jan;132(1):41-49. doi: 10.1177/00034894211067838. Epub 2022 Feb 3.
PubMed 35114808Bayramoglu B, Emre U, Erdal Y, Demirhan H, Yasak I, Yalin OO. Cervical vestibular-evoked myogenic potentials in patients with essential tremor. J Clin Neurosci. 2021 Sep;91:365-368. doi: 10.1016/j.jocn.2021.07.015. Epub 2021 Jul 30.
PubMed 34373053Jimenez-Jimenez FJ, Alonso-Navarro H, Garcia-Martin E, Agundez JAG. Sleep disorders in essential tremor: systematic review and meta-analysis. Sleep. 2020 Sep 14;43(9):zsaa039. doi: 10.1093/sleep/zsaa039.
PubMed 32163585Bugalho P, Salavisa M, Borbinha C, Fernandes M, Meira B, Barbosa R, Mendonca M. REM sleep behaviour disorder in essential tremor: A polysomnographic study. J Sleep Res. 2021 Apr;30(2):e13050. doi: 10.1111/jsr.13050. Epub 2020 Apr 23.
PubMed 32323893Rekik A, Nasri A, Mrabet S, Gharbi A, Souissi A, Gargouri A, Kacem I, Gouider R. Non-motor features of essential tremor with midline distribution. Neurol Sci. 2022 Oct;43(10):5917-5925. doi: 10.1007/s10072-022-06262-x. Epub 2022 Jul 18.
PubMed 35849198
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effects of Repetitive Transcranial Magnetic Stimulation and Mechanisms in Clinical Function of Essential Tremor
- ClinicalTrials.gov ID
- NCT06145932
- Acronym / sponsor ID
- rTMS / JD-LK2023096-IR01
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and electrophysiology of repetitive transcranial magnetic stimulation in the treatment of essential tremor.
Detailed description
This is a randomized controlled study.The purpose is to evaluate the efficacy of repetitive transcranial magnetic stimulation(rTMS) in the treatment of essential tremor,and explore the possible mechanism by detecting the changes of clinical scale and TMS-electroencephalogram(TMS-EEG), so as to seek an effective therapy for essential tremor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS treatment group | Experimental | Device: real rTMStreated with real rTMS 1800 pulses / day,for 10 days |
| Sham rTMS treatment group | Sham comparator | Device: sham rTMStreated with sham rTMS 1800 pulses / day,for 10 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed as essential tremor conforming to the diagnostic criteria for essential tremor in the tremor group of the International Parkinson's and Movement Disorders Society (IPMDS).
- Signed informed consent form.
Key exclusion criteria (4 listed)
- Complicated with brain organic diseases, epilepsy, other mental diseases, family history of dementia, metal devices implanted in the body and any contraindications to TMS;
- History of craniocerebral surgery;
- TMS cannot cooperate;
- TMS-EEG examination artifacts are obvious, or cannot be analyzed due to other technical reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real rTMStreated with 1HZ rTMS 1800 pulses / day,for 10 days | Device | rTMS treatment group |
| sham rTMStreated with sham rTMS 1800 pulses / day,for 10 days | Device | Sham rTMS treatment group |
Primary outcome
The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score
Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
The TETRAS is widely used tremor evaluation scale.TETRAS has been used for evaluation tremor in patients with essential tremor focuses primarily on the assessment of activities of daily living and tremor.The TETRAS score ranges from 0 to 112. The higher the TETRAS score, the more severe the symptoms.
Changes from baseline in tremor analysis
Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
This outcome reflects quantitative changes in the patient's tremor.
13 secondary outcomes
Changes from baseline in TMS-EEG
Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Change in Non-Motor Symptoms Rating Scale (NMSS) score from baseline
Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Change in Mini-Mental State Examination (MMSE) score from baseline
Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Change in Montreal Cognitive Assessment (MOCA) score from baseline
Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Changes from baseline in Hamilton Anxiety Scale(HAMA) score
Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score
Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Quality of Life Questionnaire (QUEST) score change from baseline
Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline
Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Change in Fatigue Severity Scale (FSS) score from baseline
Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
RBD Screening Questionnaire (RBDSQ) score
Time frame: visit 1(baseline)
Test the sleep characteristics by polysomnography (PSG)
Time frame: visit 1(baseline)
test the characteristics of vestibular evoked myogenic potential (VEMP)
Time frame: visit 1(baseline)
test the gene's type of the notch2nlc
Time frame: visit 1(baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 11890845Gironell A, Kulisevsky J, Lorenzo J, Barbanoj M, Pascual-Sedano B, Otermin P. Transcranial magnetic stimulation of the cerebellum in essential tremor: a controlled study. Arch Neurol. 2002 Mar;59(3):413-7. doi: 10.1001/archneur.59.3.413.
- Background: PubMed 36806734Lv Y, Wang M, Yang J, Shi J, Xuan T, Zhang J, Du D, Cheng J, Li H. Cerebellar repetitive transcranial magnetic stimulation versus propranolol for essential tremor. Brain Behav. 2023 Mar;13(3):e2926. doi: 10.1002/brb3.2926. Epub 2023 Feb 17.
- Background: PubMed 20175185Louis ED, Ferreira JJ. How common is the most common adult movement disorder? Update on the worldwide prevalence of essential tremor. Mov Disord. 2010 Apr 15;25(5):534-41. doi: 10.1002/mds.22838.
- Background: PubMed 30625472Louis ED. The Roles of Age and Aging in Essential Tremor: An Epidemiological Perspective. Neuroepidemiology. 2019;52(1-2):111-118. doi: 10.1159/000492831. Epub 2019 Jan 9.
- Background: PubMed 37199795Bal N, Sengul Y, Behmen MB, Powell A, Louis ED. Vestibular reflexes in essential tremor: abnormalities of ocular and cervical vestibular-evoked myogenic potentials are associated with the cerebellum and brainstem involvement. J Neural Transm (Vienna). 2023 Dec;130(12):1553-1559. doi: 10.1007/s00702-023-02652-3. Epub 2023 May 18.
- Background: PubMed 35114808Berkiten G, Tutar B, Atar S, Kumral TL, Salturk Z, Akan O, Sari H, Onaran O, Biltekin Tuna O, Uyar Y. Assessment of the Clinical Use of Vestibular Evoked Myogenic Potentials and the Video Head Impulse Test in the Diagnosis of Early-Stage Parkinson's Disease. Ann Otol Rhinol Laryngol. 2023 Jan;132(1):41-49. doi: 10.1177/00034894211067838. Epub 2022 Feb 3.
- Background: PubMed 34373053Bayramoglu B, Emre U, Erdal Y, Demirhan H, Yasak I, Yalin OO. Cervical vestibular-evoked myogenic potentials in patients with essential tremor. J Clin Neurosci. 2021 Sep;91:365-368. doi: 10.1016/j.jocn.2021.07.015. Epub 2021 Jul 30.
- Background: PubMed 32163585Jimenez-Jimenez FJ, Alonso-Navarro H, Garcia-Martin E, Agundez JAG. Sleep disorders in essential tremor: systematic review and meta-analysis. Sleep. 2020 Sep 14;43(9):zsaa039. doi: 10.1093/sleep/zsaa039.
- Background: PubMed 32323893Bugalho P, Salavisa M, Borbinha C, Fernandes M, Meira B, Barbosa R, Mendonca M. REM sleep behaviour disorder in essential tremor: A polysomnographic study. J Sleep Res. 2021 Apr;30(2):e13050. doi: 10.1111/jsr.13050. Epub 2020 Apr 23.
- Background: PubMed 35849198Rekik A, Nasri A, Mrabet S, Gharbi A, Souissi A, Gargouri A, Kacem I, Gouider R. Non-motor features of essential tremor with midline distribution. Neurol Sci. 2022 Oct;43(10):5917-5925. doi: 10.1007/s10072-022-06262-x. Epub 2022 Jul 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chun-Feng Liu principal investigator
Second Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real rTMS in people with Essential Tremor, run by Second Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun-Feng Liu, MD (+8613606210609, liuchunfeng@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score (time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145932, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.